Synovasure® Alpha Defensin
The Synovasure® Alpha Defensin test is a laboratory developed test (LDT) for the detection of infection in the synovial fluid (joint fluid) of patients experiencing pain and/or inflammation in a joint. Synovasure® Alpha Defensin is a panel of tests available in two formats: Synovasure Alpha Defensin for Periprosthetic Joint Infection (PJI) and Synovasure Alpha Defensin for Native Septic Arthritis (NSA).
The panel capitalizes on the diagnostic characteristics of alpha defensin, and also includes an adjustment for samples with significant amounts of bloody contamination or hemolysis. Furthermore, the inclusion of a synovial fluid CRP test in the Synovasure Alpha Defensin panel provides for the identification of samples that are most likely to represent false positive results, due to confounding conditions such as metallosis. The test maintains its diagnostic performance even among patients with systemic inflammatory diseases, patients on antibiotics and patients experiencing the effects of metal products. The sensitivity and specificity of the test are as follows:
|Synovasure Alpha Defensin Test||95% Confidence Interval|
|Sensitivity||97.4%||86.1% – 99.6%|
|Specificity (excluding cases of metallosis)||97.1%||93.0% – 99.7%|
|Specificity (including cases of metallosis)||95.8%||90.5% – 98.6%|
Alpha defensins are biomarkers that act as the body’s natural antibiotics. They kill or inactivate a broad spectrum of bacteria, fungi, and some enveloped viruses. Alpha defensin levels are elevated when infection is present but normal in other causes of joint inflammation. Internal and external studies show that alpha defensin testing outperforms current diagnostic tests for infection.
The Synovasure Alpha Defensin test is offered through our CLIA certified laboratory, CD Laboratories® (CLIA License# 21D0216863) and has been validated using the Musculoskeletal Infection Society (MSIS) criteria. Test results are available within 24hrs. Physicians can also request a culture test along with the Synovasure Alpha Defensin Test. Culture will be run using the BACT/Alert FAN® blood culture bottles for both aerobic and anaerobic organisms.
The Synovasure Alpha Defensin test is intended for clinical use. CD Laboratories is certified under the Clinical Laboratories Improvement Amendments of 1988 (CLIA) as qualified to perform high complexity testing. Synovasure Alpha Defensin has not been reviewed by the U.S. Food and Drug Administration. This test is covered by U.S. patent 7598080.
Your test kits will be supplied by CD Diagnostics®, a division of Zimmer Biomet, and will be sent to you directly at no charge to your practice. For additional information, contact your Zimmer Biomet representative or call customer service directly at 888-981-TEST (8378).